Quality Assurance & Food Safety

FDA Finds 46% of Imported Seafood Samples Short-Weighted, Issues Labeling Guidance

The agency placed 11 foreign firms on import alert and released draft guidance on voluntary U.S.-origin labeling claims for seafood products.
JD Supra

FDA Launches Pursuit of Fit-For-Purpose Regulatory Framework to Advance Rare Disease Drug Development

On October 14, 2026, the U.S. Food and Drug Administration (FDA) launched the Rare Disease Framework Initiative (“RDF Initiative”) to develop ...
Medical Xpress

FDA drug approval affects health care around the world, but political shortcuts could hurt the agency's reputation

At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with sickle cell disease. While this is good news for children in the U.S. born ...
RAPS

FDA drafts guidance explaining 3-year clinical investigation exclusivity for new drugs

In a new draft guidance, the US Food and Drug Administration (FDA) has provided details on the clinical investigation requirements that sponsors of new drugs must meet to obtain three years of ...
The Conversation

FDA drug approval affects healthcare around the world, but political shortcuts could hurt the agency’s international reputation

At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with sickle cell disease. While this is good news for children in the U.S. born ...